Respironics, Inc. REMstar Heated Humidifer Main PCA Repair Kit, Part number 1006265 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device

Recommended Action

Per FDA guidance

The recalling firm issued a recall letter dated 10/25/06 to their domestic and Canadian dealers informing them of the problem and the need to contact the end users. These dealers were given two options: 1) contact the end user by forwarding a letter the recalling firm provided or 2) contacting the third party company with their distribution list. The recalling firm issued a recall letter dated 10/25/06 regarding the service repair kit and the need to contact end users that had the device repaired using this kit. The recalling firm issued a recall letter date 10/25/06 to the international customers informing them of the problem, contact the end users, and the need to destroy the recalled part.